目的 建立注射用益氣復(fù)脈（凍干）（YQFM）體外抗氧化活性測定方法，并對30批樣品體外抗氧化活性進行測定。方法 一定濃度的YQFM溶液與等體積的DPPH溶液混合均勻并放置一定時間后，采用紫外可見分光光度法，測定其吸收值相對于DPPH控制液（由DPPH溶液與等體積溶劑混合）的變化情況（DPPH自由基清除情況），考察波長為517 nm，并進行空白吸收考察、專屬性考察、反應(yīng)平衡時間的確定、DPPH線性考察、YQFM線性考察、精密度試驗、重復(fù)性試驗、耐用性試驗等方法學(xué)驗證；以YQFM隨行樣品作為對照，以YQFM清除DPPH自由基的半數(shù)抑制濃度（IC₅₀）和相對抗氧化強度作為衡量其抗氧化活性的指標。結(jié)果 方法學(xué)驗證結(jié)果表明，建立的體外抗氧化研究方法符合要求；30批YQFM樣品IC₅₀均值為4.07 mg/mL。結(jié)論 建立的方法適用于YQFM體外抗氧化活性測定，YQFM具有較強的抗氧化活性。

Objective To establish a method for the determination of antioxidant activity of Yiqi Fumai Lyophilized Injection (YQFM) in vitro, and determine the antioxidant activity in vitro of 30 batches of samples. Methods After a certain concentration of YQFM solution and equal volume of DPPH solution were evenly mixed and placed for a certain time, the change of absorption value relative to DPPH control solution (mixed by DPPH solution and equal volume solvent) (DPPH free radical scavenging) was determined by UV-VIS spectrophotometry. The wavelength was 517 nm, meanwhile, the blank absorption, specificity, reaction equilibrium time, DPPH linearity, YQFM linearity, precision test, repeatability test and durability test were used to verify the methodology; the IC₅₀ and relative antioxidant strength of YQFM were used as the indexes to measure the antioxidant activity of YQFM. Results The results of methodology validation showed that the established in vitro antioxidant research method met the requirements. The mean IC₅₀ of 30 samples was 4.07 mg/mL, which indicated that YQFM had strong antioxidant activity. Conclusion The method was applicable to the determination of antioxidant activity of YQFM in vitro, YQFM has strong antioxidant activity.

R965

天津市科技計劃項目（18YFCZZC00430）